A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Instruments
2.2.1. Primary Outcome
2.2.2. Secondary Outcomes
2.3. Procedure
2.4. Intervention Programme
- What is a first episode of psychosis?
- Challenge and importance of insight into vulnerability.
- Symptom recognition.
- Prevention of relapses: protective and risk factors.
- Detection of prodromes.
- What can I do if I perceive that the symptoms are emerging again?
- Treatment adherence.
- Healthy lifestyles: sleep and sexuality.
- Healthy lifestyles: substance use.
- Anxiety management techniques (I).
- Anxiety management techniques (II).
- Social skills: assertiveness techniques.
- Problem-solving techniques.
- Final doubts and farewell.
2.5. Statistical Analyses
3. Results
3.1. Sociodemographic and Clinical Baseline Characteristics of the Sample
3.2. Clinical and Functional Outcomes of FEP Patients
3.3. Influence of Clinical Improvements on Functional Outcomes
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Total (n = 177) | CBT + TAU | TAU | t/χ2 | p | |
---|---|---|---|---|---|---|
Sex | Women | 72 (40.7%) | 39 (45.3%) | 33 (36.3%) | χ2 = 1.512 | 0.219 |
Age | 28.53 ± 8.97 | 27.74 ± 7.66 | 29.27 ± 10.03 | t = −1.136 | 0.258 | |
Occupation | Employed | 69 (39.2%) | 31 (35.7%) | 39 (42.5%) | χ2 = 0.863 | |
Unemployed | 57 (32.2%) | 30 (34.5%) | 27 (29.9%) | 0.650 | ||
Student | 51 (28.7%) | 26 (29.8%) | 25 (27.6%) | |||
Education level | Primary school | 6 (3.4%) | 1 (1.4%) | 5 (5.3%) | χ2 = 2.784 | 0.249 |
Secondary school | 128 (72.1%) | 67 (77.5%) | 61 (67.1%) | |||
College | 43 (24.5%) | 18 (21.1%) | 25 (27.6%) | |||
Civil status | Single | 146 (82.5%) | 72 (83.3%) | 74 (81.6%) | χ2 = 0.136 | |
Married | 23 (12.9%) | 10 (11.9%) | 13 (13.8%) | 0.934 | ||
Divorced | 8 (4.7%) | 4 (4.8%) | 4 (4.6%) | |||
Diagnosis | Non-specified psychotic disorder | 118 (66.7%) | 58 (67.4%) | 60 (65.9%) | χ2 = 2.500 | 0.776 |
Bipolar disorder with psychotic symptoms | 23 (13%) | 13 (15.1%) | 10 (11%) | |||
Schizophreniform disorder | 17 (9.6%) | 6 (7%) | 11 (12.1%) | |||
Brief psychotic disorder | 13 (7.3%) | 6 (7%) | 7 (7.7%) | |||
Major depressive disorder with psychotic symptoms | 3 (1.7%) | 1 (1.2%) | 2 (2.2%) | |||
Delusional disorder | 3 (1.7%) | 2 (2.3%) | 1 (1.1%) | |||
Treatment | Antipsychotics | 171 (97.2% | 85 (98.8%) | 86 (95.6%) | χ2 = 1.716 | 0.190 |
Benzodiazepines | 77 (43.8%9 | 35 (40.7%) | 42 (46.7%) | χ2 = 0.637 | 0.425 | |
Mood stabilisers | 24 (13.6%) | 12 (14%) | 12 (13.3%) | χ2 = 0.014 | 0.905 | |
Antidepressants | 20 (11.4%) | 11 (12.8%) | 9 (10%) | χ2 = 0.340 | 0.560 | |
FAST | 31.61 ± 15.81 | 33,09 ± 15,519 | 30,16 ± 16,053 | t = −1.218 | 0.225 | |
GAF | 58.54 ± 11.0 | 59.63 ± 9.99 | 56.78 ± 11.82 | t = 1.133 | 0.259 | |
CGI-S | 7.64 ± 5.75 | 7.74 ± 5.94 | 7.55 ± 5.60 | t = 0.224 | 0.823 | |
CGI-I | 8.65 ± 7.77 | 9.06 ± 8.10 | 8.26 ± 7.46 | t = 0.677 | 0.499 | |
PANSS P | 14.16 ± 6.95 | 13.40 ± 6.46 | 15.36 ± 7.71 | t = −1.960 | 0.052 | |
PANSS N | 13.69 ± 6.27 | 14.48 ± 6.96 | 13.19 ± 5.83 | t = 1.635 | 0.104 | |
PANSS PG | 29.19 ± 7.98 | 29.64 ± 8.68 | 28.77 ± 7.2 | t = 0.886 | 0.377 | |
HDRS | 11.75 ± 7.40 | 12.46 ± 8.22 | 11.07 ± 6.51 | t = 1.241 | 0.219 | |
STAI-State | 24.82 ± 10.90 | 23.87 ± 10.96 | 26.14 ± 10.59 | t = −0.892 | 0.374 | |
SUMD | 4.94 ± 3.18 | 5.50 ± 3.05 | 5.47 ± 3.95 | t = −0.054 | 0.957 | |
MMAS | 97 (54.8%) | 52 (60.0%) | 45 (49.4%) | χ2 = 1.940 | 0.164 | |
BDNF (pg/Ml) | 6.95 ± 5.77 | 7.66 ± 6.79 | 6.49 ± 5.05 | t = −0.839 | 0.404 |
Group | CBT + TAU | TAU | ||||
---|---|---|---|---|---|---|
Variable | Pre | Post | t (p) | Pre | Post | t (p) |
FAST | 33.43 ± 15.531 | 15.15 ± 16.425 | 7.638 (≤0.001) | 30.96 ± 20.05 | 20.05 ± 15.221 | 6.109 (≤0.001) |
GAF | 61.24 ± 10.62 | 76.03 ± 13.60 | −7.669 (≤0.001) | 56.92 ± 12.03 | 69.58 ± 13.91 | −7.310 (0.001) |
CGI-S | 6.74 ± 5.43 | 6.09 ± 6.61 | 1.519 (0.133) | 7.16 ± 5.41 | 6.99 ± 6.68 | 0.380 (0.705) |
CGI-I | 8.08 ± 7.81 | 7.07 ± 7.57 | 2.131 (0.037) | 7.48 ± 7.03 | 6.25 ± 6.09 | 3.033 (0.003) |
Panns P | 13.34 ± 6.44 | 8.47 ± 3.22 | 6.365 (≤0.001) | 15.39 ± 7.66 | 10.39 ± 4.90 | 5.705 (≤0.01) |
Panns N | 14.78 ± 7.49 | 10.55 ± 5.71 | 5.394 (≤0.001) | 13.41 ± 6.29 | 11.39 ± 5.43 | 3.787 (≤0.001) |
Panns G | 30.17 ± 10.33 | 21.35 ± 7.60 | 6.738 (≤0.001) | 28.81 ± 7.29 | 23.33 ± 6.67 | 6.861 (≤0.001) |
HDRS | 12.31 ± 8.31 | 5.24 ± 5.58 | 6.434 (≤0.001) | 11.30 ± 6.28 | 6.65 ± 4.96 | 8.066 (≤0.001) |
STAI-State | 24.11 ± 10.91 | 19.05 ± 9.18 | 3.192 (0.002) | 25.97 ± 11.30 | 21.28 ± 7.93 | 3.309 (0.002) |
SUMD | 4.67 ± 3.05 | 3.07 ± 2.88 | 6.067 (≤0.001) | 4.64 ± 2.97 | 3.93 ± 3.03 | 2.697 (0.008) |
MMAS (good) 1 | 51 (60.0%) | 55 (72.4%) | p = 0.052 1 | 38 (43.7%) | 36 (45.6%) | p = 0.690 1 |
BDNF (pg/Ml) | 7.66 ± 6.79 | 9.76 ± 6.78 | −1.760; (0.090) | 6.49 ± 5005 | 6.95 ± 4.39 | −0.675 (0.503) |
Variable | CBT + TAU Δ | TAU Δ | F | p | |
---|---|---|---|---|---|
FAST | −18.28 ± 20.73 | −10.91 ± 15.88 | 5.468 | 0.021 | 0.04 |
GAF | 14.79 ± 16.70 | 12.66 ± 15.78 | 6.269 | 0.013 | 0.04 |
CGI-S | −0.65 ± 3.66 | −0.17 ± 3.98 | 0.605 | 0.438 | 0.00 |
CGI-I | −1.01 ± 3.98 | −1.24 ± 3.62 | 0.379 | 0.539 | 0.00 |
Panns P | −4.87 ± 6.67 | −5.00 ± 7.94 | 6.214 | 0.014 | 0.04 |
Panns N | −4.22 ± 6.83 | −2.02 ± 4.84 | 4.008 | 0.047 | 0.03 |
Panns G | −8.83 ± 11.34 | −5.48 ± 7.19 | 4.626 | 0.033 | 0.03 |
HDRS | −7.07 ± 9.51 | −4.65 ± 5.16 | 4.078 | 0.045 | 0.03 |
STAI State | −5.05 ± 11.95 | −4.69 ± 11.69 | 1.494 | 0.224 | 0.01 |
SUMD | −1.60 ± 2.28 | −0.71 ± 2.43 | 6.564 | 0.011 | 0.04 |
MMAS (good) 1 | 12.4% | 1.9% | 1.002 | 0.007 | 2.723 |
BDNF (pg/Ml) | 2.10 ± 6.30 | 0.46 ± 4.55 | 3.923 | 0.050 | 0.05 |
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González-Ortega, I.; Vega, P.; Echeburúa, E.; Alberich, S.; Fernández-Sevillano, J.; Barbeito, S.; Balanzá-Martínez, V.; Vieta, E.; Lorente-Rovira, E.; Luengo, A.; et al. A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis. Int. J. Environ. Res. Public Health 2021, 18, 7239. https://doi.org/10.3390/ijerph18147239
González-Ortega I, Vega P, Echeburúa E, Alberich S, Fernández-Sevillano J, Barbeito S, Balanzá-Martínez V, Vieta E, Lorente-Rovira E, Luengo A, et al. A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis. International Journal of Environmental Research and Public Health. 2021; 18(14):7239. https://doi.org/10.3390/ijerph18147239
Chicago/Turabian StyleGonzález-Ortega, Itxaso, Patricia Vega, Enrique Echeburúa, Susana Alberich, Jessica Fernández-Sevillano, Sara Barbeito, Vicent Balanzá-Martínez, Eduard Vieta, Esther Lorente-Rovira, Ana Luengo, and et al. 2021. "A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis" International Journal of Environmental Research and Public Health 18, no. 14: 7239. https://doi.org/10.3390/ijerph18147239